Quickly: What three technologies impact your drug development and manufacturing? How do those technologies impact your outsourcing partners, processes, and decisions? Thanks for joining today’s flash mind exercise. You’ve also joined executives on the Outsourced Pharma Editorial Advisory Board who did the same. Let’s compare.
When the U.S. Supreme Court granted certiorari in the Sandoz v. Amgen litigation earlier this year, many were hoping for a decision that would clarify some key issues pertaining to the requirements of the BPCIA. But the decision left a number of questions unanswered.
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This four-part article provides a foundational introduction to some of those aspects.
It seems blockchain technology is following the hype path the cloud did a few years ago. The most talked-about example of blockchain is Bitcoin, a digital currency that does not rely on a central authority (such as the Federal Reserve) to clear financial transactions. A few short months ago, the word “blockchain” was seldom mentioned in supply chain circles. Now, it’s not uncommon to be asked what your blockchain strategy is within those same circles. What has changed is its successful use and blockchain platforms adding functionality.
In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.
Formulation scientistsmust develop and validat robust systems that address the challenges posed by increasingly complex drug candidates, in ever shortening time frames.
Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.
In this application note, three standard field service procedures for TruDO sensors are described: replacement of the membrane, refilling of the electrolyte solution, and cleaning/replacement of the cathode.
The growing public awareness of a potential pandemic requiring rapid treatment of millions of healthy individuals has spurred renewed interest in vaccines. Vaccine development timelines vary from being only a fraction of other biotherapeutics to decades of research and efforts to find an effective vaccine. Vaccination campaigns mean that often very large quantities need to be manufactured, maintained, and distributed.
An innovative biotechnology company exploring novel therapeutics for neuroscience indications had developed a promising new chemical entity for the treatment of a severe pediatric genetic disease. However, numerous drug delivery challenges threatened the realization of the Fast Track status designation they had received due to promising early stage results. By leveraging a softgel technology, the customer was able to overcome a number of potential hurdles and expeditiously enter the Phase II/III clinical trial.
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Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
To continue the evolution of single-use technology (SUT) in biopharma, one area that must be secured is SUT supply chain reliability. Without this, a larger scale adoption of SUT may continue to be delayed as biopharmaceutical manufacturers must have access to a reliable supply chain that allows us to successfully deliver product to our customers.
Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks.
Due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.
When selecting a bioreactor, you can choose stainless steel or single-use technologies, depending on your biomanufacturing requirements. The bioreactor is a key component of your bioprocessing workflow and should be regarded as a strategic asset. It is important that this core technology is carefully chosen, specified, designed, and supported, both now and in the future.
When planning for the development of a new product, a pharmaceutical manufacturer must determine very early in the process what a product’s anticipated demand will be at the time of launch. Not only is this very difficult to do, but also the consequences of incorrect forecasts can be very costly in a number of ways. Without the ability to predict capacity needs with 100% accuracy, pharma must come up with an effective way to eliminate demand risks.